Neurotech International Limited

ASX:NTI

Neurotech International Limited

ASX:NTI
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Forum Topics NTI NTI Phase 11/111 Autism Trial

Pinned straw:
Scoonie
Added 3 months ago

As documented everywhere, NEU has had a spectacular run with their drug Daybue and the up and coming drug NNZ2591. 

The NNZ2591 Phase 2 topline results for the treatment of Phelan-McDermid Syndrome (PMS) were released to the market on the 18/12/23.

And the results were impressive, in short:

  • “Clinical Global Impression of Improvement (CGI-I) – mean score of 2.4 with 16 out of 18 children showing improvement assessed by clinicians.
  • Caregiver Overall Impression of Change (CIC) – mean score of 2.7 with 15 out of 18 children showing improvement assessed by caregivers.”


The NEU PMS trial was a Phase 2, 13 week, open label undertaken on just 18 children.

In the immediate days following the release of the results NEU share price went from around to $16 to a peak of $24.50.

This represented an increase in NEU’s market capitalisation of around $1b.  

However given the sales potential of a successful NNZ2591 drug for PMS and then potentially the other in-their-sights orphan conditions, we all can appreciate why.

 

Neurotech International (NTI), this month released Phase 2/3 results for their cannabis derived drug NT1164 on Autism Spectrum Disorder. In NTI’s release the trial design and purpose was:

“NTIASD2 is a Phase II/III Double-Blind, Randomised and Controlled-to-Open-Label Study to assess the efficacy of NTI164 up to 20mg/kg/day on the severity of spectrum disorder (ASD) in up to 54 patients aged 2-17 years (inclusive).”


The improvement results whilst not good as NEU’s PMS trial, were pretty solid:           

“NTIASD2 Phase II/III clinical trial met the primary endpoint of a statistically significant improvement in severity of illness (CGI-S) at 8 weeks between NTI164 and placebo (p<0.001) • Children in NTI164 group re-classified from markedly-severely ill (CGI-S: 5.54) at baseline to mild-moderately ill (CGI-S: 3.77) at 8 weeks, a very strong improvement ><0.001)

Children in NTI164 group re-classified from markedly-severely ill (CGI-S: 5.54) at baseline to mild-moderately ill (CGI-S: 3.77) at 8 weeks, a very strong improvement.”

The response from the market to NTI’s announcement was flaccid with the M/cap rising just $9m and since falling back to below the post announcement level.


Without trying to sound like a pal of Mr Culper, the NEU PMS Ph2 trial was open label and only tested 18 children.  And there are a lot more ASD than PMS suffers.   

Three years ago John Pilcher was running just another cash starved on-the-bones-of-its-arse biotech hopeful.


Is NTI shorthand for Not To Invest or is there something being missed?  
mikebrisy
3 months ago

Good question. I guess $NTI is earlier in the process, is a big part of it.

I haven't spent a lot of time looking at the last investor presentation, but it is not clear to me what the pathway ahead to NTI164 commercialisation for ASD is. On the basis of the Phase II/III result, it looks to have some promise, given that there is no FDA-approved drug for the treatment of the any of the core domains of symptoms for ASD. (Rispiridone being approved for behavioural - irritability - only).

However, the readout is also a preliminary one, so I think we need to see what happens with the more complete report. (But, you are right to point out that NNZ-2591 was also a preliminary readout).

On Retts, the data seems to show not as good a clinical effect as DAYBUE but better tolerability - I guess the question is what the results look like in the next phase, and whether the improved safety/tolerability gets it over the line with orphan designation? Which will be key. It then faces being second to market by several years, which puts it on the back foot unless it is clearly superior.

The other point is that $NTI - even with its completed $10m capital raise - it pretty lightly funded. $NEU raised more cash earlier I think. So I imagine shareholder of $NTI face a fair bit of dilution ahead. Maybe mixing up the report with the CR presentation took some of the focus off the result?

But certainly, it is an interesting one to track, and I agree - I haven't answered the question about the lack of a SP response.

There are others here more across the interpretation of the clinical data, so I am also interested in others' views too.

My superficial bottom line: 1) earlier in the process 2) unclear what the path to commercialisation is 3) funding and dilution to getting to revenues. Quite a way to go, vs. $NEU $0.25bn in the bank, generating revenuez, multiple trials advancing with CY2024 newsflow ahead, so its on everyone's radar screens, and therefore market is more sensistive to newsflow.

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